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Completed

NCT Number: NCT05155371

Titration of Intraoperative PEEP in Patients Undergoing Robotic Assisted Laparoscopic Prostatectomy

Optimal intraoperative positive end expiratory pressure (PEEP) improves the outcome. Optimal PEEP is not only very different among individuals, but each individual's optimal PEEP is affected by positioning, muscle paralysis, and several other factors. Several techniques have been used to determine the optimal PEEP. For example, electrical impedance tomography(EIT)can be performed at the bedside.However, the application of this technique requires special training, increases the workload of the care team, and the cost-efficiencyof this procedure remains to be determined.We hypothesized that optimal PEEP could be obtained by titration of intraoperative PEEP levels and FiO2with SpO2 guidance. Our secondary hypothesis was that maintenance of intraoperative optimal PEEP derived via this method improves intraoperative oxygenation and reduces the incidence of postoperative hypoxemia.We tested our hypothesis in patients undergoing robotic-assisted laparoscopic prostatectomy.

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

270 Dongan Road, Fudan University Shanghai Cancer Center, Shanghai, China

Loading trial locations.

About this study

Lung-protective ventilation strategies are recommended for patients under mechanical ventilation with intermediate-risk and high-risk in order to minimize lung injury and respiratory complications of critically ill patients associated with mechanical ventilation , such as atelectasis and pneumonia. Low tidal volume (TV) had been proven protective . However, there is no consensus on what the optimal positive end expiatory pressure (PEEP) is for patients with healthy lungs undergoing general anesthesia, particularly for those who are undergoing abdominal surgery. A recent study showed that electrical impedance tomography (EIT) could be used to identify optimal PEEP, where both lungs collapse, hyper-insufflation is minimized, and the variation of optimal PEEP in patients with healthy lungs undergoing abdominal surgery is profound.Therefore, a fixed PEEP applied to all patients surely over-PEEP some and under-PEEP others. This study also demonstrates that maintaining the optimal PEEP intra-operatively not only improves intra-operative oxygenation but also reduces the incidence and severity of atelectasis post-operatively . Even though this study focuses on the improvement of physiology rather than the outcome, the benefit of intra-operative optimal PEEP is sustained for at least for one-hour post extubation. Therefore, optimized intra-operative PEEP could potentially have a positive impact onoutcomes. However, the cost-effectiveness of EIT used intraoperatively as routine practice still needs to be determined. Development of new methods which can be used intraoperatively and arecost-effective and user-friendly is an unmet demand.

Recently, Ferrando et al conducted a study in which the authors used minimal FiO2 to maintain clinically acceptable arterial blood O2 saturation by titrating PEEP. Even though this study was not randomized and sample size was insufficient to demonstrate improved outcomes, it clearly demonstrated its feasibility and safety. We hypothesize that titration of intraoperative PEEP using minimal FiO2 while maintaining clinically acceptable O2 saturation allows clinicians to identify the optimal PEEP. We will test this hypothesis on patients undegoing RALP. We chose this population because these patients have increased number of postoperative complications . Additionally, physicians are prone to using suboptimal ventilation strategies such as inappropriate tidal volumes and intraoperative PEEP in this population; therefore these patients are more likely to achieve maximal benefit with optimized intra-operative PEEP.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult patients aged 18 years or older
  • scheduled for elective robotic-assisted laparoscopic prostatectomy(RALP)
  • ASA physical status of I-III

Exclusion criteria

  • acute or chronic respiratory disorders
  • pulmonary hypertension
  • neuromuscular disease
  • preoperative SpO2<95% on room air

Treatment and study plan

Titration of Optimal Positive End-expiratory Pressure

Other

Titration of Optimal Positive End-expiratory Pressure with two different methods

Primary outcomes

  1. The difference of optimal PEEP titrated by two methods

    Time frame: within 30 minutes after trachea intubation

    Titration result of the two groups

Secondary outcomes

  1. Difference of intraoperative PaO2/FiO2 between the two groups

    Time frame: 30,60,120 minutes after finishing PEEP titration

    intraoperative PaO2/FiO2 between the two groups

  2. Difference of intraoperative driving pressure, dynamic compliance between the two groups

    Time frame: 30,60,120 minutes after finishing PEEP titration

    Difference of intraoperative driving pressure, dynamic compliance between the two groups

  3. Difference of lung regional ventilation between the two groups

    Time frame: 5 minutes after trachea extubation

    lung regional ventilation recorded by EIT

  4. Post operation hypoxemia in PACU.

    Time frame: within 30 minutes after trachea extubation

    Postoperative hypoxemia was defined as postoperative hypoxemia if SpO2<92%was detected in room air within 30 min after extubation in the PACU

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study title

Titration of Intraoperative Positive End-expiratory Pressure to Optimize Gas Exchange in Patients Undergoing Robotic Assisted Laparoscopic Prostatectomy

Acronym: TIPPR

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Dec 13, 2021
Registry last updated
Feb 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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